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Trial record 1 of 1 for:    NCT04943172
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The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study

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ClinicalTrials.gov Identifier: NCT04943172
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : February 1, 2023
Sponsor:
Collaborators:
AXIOM Real Time Metrics
Syntactx
Information provided by (Responsible Party):
Hancock Jaffe Laboratiores, Inc

Study Description
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Brief Summary:
A prospective, non blinded, single arm, multicenter study designed to assess the safety and effectiveness of the bioprosthetic, VenoValve, which is surgically implanted into the deep venous system for treatment of patients with deep venous valvular insufficiency ( C4b-C6 patients).

Condition or disease Intervention/treatment Phase
Deep Venous Insufficiency (Diagnosis) Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®) Not Applicable

Detailed Description:
The purpose of this study is to evaluate the VenoValve System (Hancock Jaffe Laboratories) in human patients. The VenoValve System is designed for treatment of chronic deep venous insufficiency. The VenoValve System enables improvement in chronic lower extremity venous reflux through an open surgical technique. The objective of this study is to assess the safety and effectiveness of the VenoValve System for the treatment of patients with deep venous valvular insufficiency and the associated complications.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: VenoValve
Subjects who receive VenoValve implant
 Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®)
Surgical implantation of the VenoValve device


Outcome Measures
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Primary Outcome Measures :
  1. The primary safety endpoint is the composite of the following Major Adverse Events: [ Time Frame: 30 days ]
    Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, Pulmonary embolism in 75 patients. Rate of >9% is expected


Secondary Outcome Measures :
  1. Major Adverse Event rates [ Time Frame: 3, 6, 12 months and annually thereafter through 5 years ]
    Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, and Pulmonary Embolism


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Failure of at least 3 months of standard care including compression therapy, and in C6 patients, wound care,
  2. Axial deep reflux >1000 msec. at the level of the popliteal vein
  3. Venous valvular incompetence from primary or secondary causes, e.g., post-thrombotic syndrome (PTS),
  4. CEAP score: C4b, C4c, C5, or C6,
  5. Diameter of native target vein ≥8 mm,
  6. Age ≥18 years,
  7. Ability to tolerate duplex ultrasound,
  8. Ability to ambulate without assistance,
  9. Able to attend scheduled post-treatment follow-up visits,
  10. BMI <40,
  11. Willing and able to comply with all compulsory study procedures and provide informed consent prior to any study procedures being performed,
  12. Negative COVID-19 test within 6 days of index procedure or record of full vaccination for COVID-19,

  13. Female patients of childbearing potential must:

    • have negative pregnancy test at the screening visit or within 7 days of the index procedure, whichever is later,
    • not be breastfeeding or plan to breastfeed through completion of the study,
    • agree to use a medically acceptable method of preventing conception from the screening visit through completion of the study.

Exclusion Criteria:

  1. Presence of superficial reflux,
  2. Presence of untreated iliac/IVC obstruction greater than 50% in diameter reduction,
  3. Previously documented hypercoagulable condition that cannot be adequately treated with anticoagulation,
  4. Previous open surgical procedure in the ipsilateral deep venous system,
  5. Venous stent in the ipsilateral femoral or popliteal vein,
  6. Extensive infrainguinal obstruction of the venous system,
  7. DVT or pulmonary embolism within 30 days of the planned procedure,
  8. Active malignancy excepting non-melanoma skin cancer,
  9. Arterial insufficiency with measured ABI <0.70
  10. Lymphedema not due to venous disease,
  11. Current or planned participation in another clinical trial within 30 days of treatment,
  12. Minor venous procedures (e.g., superficial vein procedures or venous stenting) within 6 weeks of screening,
  13. New York Heart Association Class III or greater,
  14. Fibromyalgia,
  15. Chronic narcotic usage,
  16. Positive COVID-19 test within the last 3 months.
  17. Other medical conditions or comorbidities which, in the opinion of the investigator, would interfere with study compliance,
  18. Contraindication to anticoagulation,
  19. Stainless steel sensitivity/ porcine tissue sensitivity,
  20. Active superficial thrombophlebitis,
  21. Thrombocytosis with platelet count > 1 million/microliter,
  22. Unwilling or unable to comply with post-operative anticoagulation regimen.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04943172


Contacts
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Contact: Kevin Belteau 813-713-6210 KBelteau@envveno.com
Contact: Marc Glickman, MD 757-573-7518 MGlickman@envveno.com

Locations
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Sponsors and Collaborators
Hancock Jaffe Laboratiores, Inc
AXIOM Real Time Metrics
Syntactx
Investigators
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Study Director: Marc Glickman, MD Hancock Jaffe Laboratories, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hancock Jaffe Laboratiores, Inc
ClinicalTrials.gov Identifier: NCT04943172    
Other Study ID Numbers: P061
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases